EXoPred for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to develop a test to diagnose early-stage cancers such as lung, breast, colorectal, pancreatic, and ovarian cancer. It uses a technique called SERS (a type of light analysis) to study tiny particles in the blood, aided by artificial intelligence. The trial seeks individuals aged 45 and older who have recently been diagnosed with one of these cancers but have not yet started treatment. Participants must be willing to provide a blood sample and adhere to the study requirements.
As an unphased study, participation offers the opportunity to contribute to groundbreaking research that could revolutionize early cancer detection.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, it does mention that participants should not have received any treatment related to their cancer prior to the study.
What prior data suggests that this diagnostic test is safe for cancer diagnosis?
Research shows that EXoPred, the treatment under study in the EXoPERT EMERALD Clinical Study, has varying safety results depending on the cancer type.
For ovarian cancer, long-term studies provide strong evidence that targeted therapies are generally safe and well-tolerated.
In breast cancer, the safety of treatments like exemestane, which helps prevent invasive breast cancer, is well-documented. One large study found that exemestane lowered cancer risk with manageable side effects.
For lung cancer, research on immunotherapy drugs like pembrolizumab indicates they are generally safe, even for patients with extensive prior treatments.
Pancreatic cancer treatments can sometimes have more side effects, but they also improve patient outcomes, suggesting a balance between benefits and risks.
Lastly, for colorectal cancer, a review of several studies found that current treatments are generally safe.
These findings suggest that EXoPred might be well-tolerated across different cancer types, although specific safety data for EXoPred itself is not provided here.12345Why are researchers excited about this trial?
Researchers are excited about the EXoPERT EMERALD Clinical Study because it explores innovative approaches to treating various cancers, including ovarian, breast, lung, pancreatic, and colorectal cancers. Unlike standard treatments that often rely on chemotherapy or targeted therapies, this study is investigating new methodologies that could enhance treatment effectiveness and safety. The goal is to potentially discover more precise ways to target cancer cells, minimizing harm to healthy cells and reducing side effects. If successful, these new approaches could significantly improve patient outcomes and quality of life compared to existing options.
What evidence suggests that the EXoPred diagnostic test is effective for early-stage cancer diagnosis?
This trial will evaluate the effectiveness of EXoPred in diagnosing various cancers by using advanced technology to study tiny particles called extracellular vesicles (EVs). Participants will be divided into different arms based on cancer type, including ovarian, breast, lung, pancreatic, and colorectal cancers, with a control group for comparison.
Research has shown that for ovarian cancer, using disease indicators, known as biomarkers, along with machine learning, can better predict patient outcomes. In breast cancer, blood tests that identify high-risk patients show promise for early diagnosis and treatment. For lung cancer, improved therapies are needed, and combining different treatments has shown better results. New treatments for pancreatic cancer have led to partial tumor shrinkage in many patients. Lastly, new screening tests for colorectal cancer have been very effective at detecting early-stage cancer. These findings suggest that EXoPred's method could improve diagnosis and treatment strategies for these cancers.678910Who Is on the Research Team?
Jonathan Dudley, MD
Principal Investigator
Johns Hopkins University
Saeed Jortani, Ph.D.
Principal Investigator
Kentucky Clinical Trial Laboratory
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Diagnostic Testing
Participants undergo in vitro diagnostic testing using surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EV) to diagnose multiple cancers
Follow-up
Participants are monitored for test performance and algorithm validation over the study period
What Are the Treatments Tested in This Trial?
Interventions
- EXoPred
Find a Clinic Near You
Who Is Running the Clinical Trial?
EXoPERT
Lead Sponsor
MCRA
Industry Sponsor